Medical Scientific Liaison At Abbott
Core Job Responsibilities:
Ensure that all activities and interactions are conducted with due regard to all applicable local, global and national laws, regulations, guidelines, codes of conduct, Company policies and accepted standards of best practice.
Provide scientific and technical support for, and help maintain professional and credible relationships with, key opinion leaders and academic centers to ensure access to current medical and scientific information on the products and areas of therapeutic interest.
Assist in the initiation, oversight and follow up of assigned clinical studies and medical projects initiated within the relevant therapeutic area for which the MSL carries responsibility (e.g. post marketing clinical activities such as registry/database projects, epidemiological surveys, post-authorization studies (phase IV), IIS projects, etc.): all activities to comply with applicable local laws, guidelines, codes of practice, SOPs, and Global Pharmaceutical Research and Development (GPRD) SOPs.
Maintain contacts with physicians and opinion leaders of the assigned geographic area in order to satisfy their needs for scientific knowledge in the therapeutic area and, where requested, Abbott drugs/products the MSL carries responsibility for.
Deliver credible presentations on scientific matters to physicians, individually or in groups (meetings, clinical sessions, etc.), where requested.
Participate in the selection process to identify appropriately qualified physicians the Company would wish to engage in collaborative efforts – such as potential research collaborations, or lecture/meeting support (Round Tables, Congresses, Symposia, etc.); and to ensure a high level of scientific or educational integrity in these collaborative efforts.
Develop awareness and understanding of competitor issues/intelligence – for example, product strategies, studies, commercial messages, positioning, etc – and communicate, where appropriate, within the Company.
Attend relevant Scientific meetings and Conferences/Congresses, and develop summaries of key messages for use within the Company – such as key areas of scientific/company interest, new trends in diagnosis, monitoring and treatments in the therapeutic area, etc.
Upon request, assist physicians to appropriately direct requests for access to Company products on a named patient or compassionate use basis, subject to all applicable legal and regulatory requirements.
Support sales/marketing/internal team areas to develop their scientific and technical expertise through the delivery of scientific update presentations.
Ensure up to date knowledge of products uses and external data.
Provide key opinion leaders and internal medical and clinical teams with scientific and technical support for publications of scientific or medical interest.
Pharmacovigilance Responsibilities “ASR”:
Develops & maintains the PSSF
Manages Adverse Events: Processes adverse-event case reports and conducts follow-up; notifies regulatory agencies and business partners; accordingly, responds to requests from regulatory agencies; reviews scientific literature and bibliographic sources; helps draft and manage periodic safety update reports; evaluates safety profiles; ensures document filing and archiving
Process Individual Case Safety Reports (ICSRs), including data entry in OSYRIS safety database
Ensure following-up on ICSRs with the reporter, generate follow up (FU) queries and send FU requests
Carry out ICSR local regulatory reporting, perform expedited reporting (including electronic reporting) and periodic reporting
Perform ICSRs reconciliations with business partners & other departments
Review literature screening search results, identifying ICSRs and other safety-related findings.
Write PSURS & RMPS for Local Product
Local Adaptation of PSURs (Developing National Appendix)
Local Adaptation of RMPs (Developing National Displays)
Preparing the Registration File according to 425 decree
Handle all MOH PV Submissions
To assist with pharmacovigilance processes, Trainings, supporting preparation of SOPs, product safety reviews as required
Involved in clinical trial activities, reviews the pharmacovigilance aspects of protocols and other documents; ensures management of adverse-event case reports; reconciles information in pharmacovigilance and clinical research databases
Assures compliance of pharmacovigilance activities; conducts case reconciliation with concerned departments or business partners.
Develop/Follow-up on the SDEA & PV contracts.
Requirements:
Bachelor’s Degree in medical discipline (Medicine/Clinical Pharmacy).
Minimum 2 years in similar position.
Excellent Communication and KOL-relation management skills.
Good knowledge of the relevant Therapy areas.
Excellent presentation skills.
Strong commitment to compliance with the relevant policies and procedures.
Proficiency in the English language and computer skills